(87 days)
The M1730B TraceMaster ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized electrocardiograph records from Hewlett-Packard company electrocardiograph machines.
The HP M1730B TraceMaster is an advanced data management system that automates the processing and storage of ECGs from HP PageWriter cardiographs. Its high-performance Pentium™ computer stores up to 750,000 ECGs on high-speed, online disks and produces clean, permanent traces on a HP LaserJet printer. The multitasking operating system smoothly handles the rigorous demands of simultaneous editing, printing, reception, and storage of ECGs. A powerful client/server network can spread the workload of editing, transmitting, and printing to M1776B Local Edit Stations, LAN-connected HP LaserJet printers, and M1798B Remote Edit Stations. Electrocardiograms can be transferred from HP electrocardiographs to the TraceMaster via the Local Area Network or floppy diskettes. On the Edit Stations users can then view the ECG and the interpretation performed by the electrocardiograph, compare to previous waveforms and interpretations, and overread and edit the interpretation. Remote Edit Stations can be connected via the Local Area Network or modem.
The acceptance criteria for the M1730B TraceMaster ECG System are primarily based on non-clinical performance aspects related to data management, storage, and electromagnetic compatibility. The study described in the provided text focuses on demonstrating these non-clinical aspects and comparing the device's capabilities to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Throughput Capacity | |
| Handle a specific number of ECGs per year | Up to 56,000 ECGs per year |
| Storage Capacity | |
| Store a specific number of ECGs online | 750,000 ECGs online |
| Essential Functions Compliance | |
| Meet all requirements specifications for essential functions | Tested and found to meet all requirements specifications. |
| Electromagnetic Compatibility (EMC) | |
| IEC 801-2 Compliance | Tested (included in IEC 801-2 test) |
| IEC 801-3 Compliance | Tested (included in IEC 801-3 test) |
| IEC 801-4 Compliance | Tested (included in IEC 801-4 test) |
| CISPR22:1993, class A (Emissions) Compliance | Tested for emissions of radio-frequency and mains current in accordance with CISPR22:1993, class A. |
| Equivalence to Predicate Device (functional subset) | |
| Performance is a subset of the features in the predicate device | Demonstrated that performance is a subset of the predicate device's features. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not specify a "test set" in the context of clinical data or patient ECGs. The testing described is primarily focused on the system's technical performance, not its diagnostic accuracy or clinical utility with a specific set of patient data. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature for such a test set are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the study did not involve establishing ground truth for a clinical test set from human experts. The device's function is ECG management (viewing, editing, printing, archiving), not automated interpretation.
4. Adjudication Method for the Test Set
This information is not applicable as there was no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The device's primary function is a management system, not an AI-powered diagnostic tool that directly aids human readers in interpretation. The text explicitly states, "TraceMaster does not perform any computerized interpretation of the ECG waveform."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The testing described is inherently "standalone" in the sense that it evaluates the system's technical capabilities (throughput, storage, EMC) as an algorithm/system, without reference to human interaction for diagnostic interpretation. However, it's important to clarify that this "standalone" refers to the system's technical functionality, not its diagnostic performance as an AI algorithm would typically be evaluated. The device's intended use specifies "manual editing" by users, indicating a human-in-the-loop for interpretations, though the system itself does not perform automated interpretation.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, expert consensus) is not applicable here. The "ground truth" for the non-clinical tests would be the established engineering and performance specifications for throughput, storage, and electromagnetic compliance. For example, for throughput, the ground truth is simply whether the system processes 56,000 ECGs per year.
8. The Sample Size for the Training Set
There is no mention of a training set in the context of machine learning or AI. The M1730B TraceMaster ECG System does not perform computerized interpretation, meaning it does not have an AI algorithm that would require a training set to learn from data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there was no training set for an AI algorithm.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).